Acute coronavirus disease 2019 MedDRA version: 20.1 Level: PT Classification code 10053983 Term: Corona virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Quensyl
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age above 18 years • Women of childbearing age only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year) • Disease severe enough to require hospitalisation • QTc interval lower than 450 msec Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 195 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Respiratory rate >24/min • Pregnancy or lactation • Weight <50 kg • Hemodynamic/rhythm instability • Acute myocardial infarction Type 1 • Use of concomitant medications that prolong the QT/QTc interval. • Any regular concomitant medication which is contraindicated in the use together with HCQ • Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines • Pre-existing retinopathy or maculopathy • Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism) • Haematopoietic systems diseases • Myasthenia gravis • Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: Effect of HCQ on in vivo viral clearance. ;Secondary Objective: Exploratory objectives are to assess the effect of infection and HCQ treatment on clinical outcome, cardiac function, mucosal, humoral and cellular immune response including single cell phenotype and RNA expression, effect on anti-viral defense, assessment of chronic symptoms and quality of life. ;Primary end point(s): Primary efficacy endpoint: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number =100, measured by real time reverse-transcription polymerase chain reaction in throat swabs ;Timepoint(s) of evaluation of this end point: One interim analysis for evaluating the primary efficacy endpoint is planned for this study. The interim analysis will be done when 40% of events have accrued. In case the interim analysis shows a HR > 1.93 (nominal p < 0.0018), efficacy is shown and the trial may be stopped. Final analysis upon completion of the trial and final database lock. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory endpoints: ? In-hospital mortality within 60 days ? All-cause mortality within 60 days ? Proportion requiring non-invasive ventilation ? Proportion requiring invasive ventilation ? Proportion admitted to ICU ? Duration of hospitalization ? Reduction in viral RNA load in upper respiratory tract specimen as assessed by area under viral load curve ? Reduction in viral RNA load in upper respiratory tract specimen defined as decline of RNA load by 2 log-levels or to below detection level;Timepoint(s) of evaluation of this end point: After interim and final data base lock | — |
Countries
Germany
Contacts
Public ContactProject management,Diane Egger-Adam
Universitätsklinikum Tübingen
Outcome results
None listed